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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-9740 | Registry Identifier | WHO |
Not provided
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The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.
Subjects will receive treatment for 28 weeks.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febuxostat 80 mg QD | Experimental |
| |
| Febuxostat 120 mg QD | Experimental |
| |
| Febuxostat 240 mg QD | Experimental |
| |
| Allopurinol QD | Active Comparator |
| |
| Placebo QD | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Febuxostat 80 mg, orally, once daily for up to 28 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject. | Last 3 visits (any last 3 visits up to week 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized. | Week 28 |
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18975369 | Result | Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8. doi: 10.1002/art.24209. | |
| 18600509 |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
Not provided
Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.
Subjects were enrolled at 167 investigative sites in the United States from 21 February 2003 to 07 April 2004.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 28 weeks. |
| FG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 28 weeks. |
| FG002 | Febuxostat 240 mg QD | Febuxostat 240 mg, orally, once daily for up to 28 weeks. |
| FG003 | Allopurinol QD | Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily. |
| FG004 | Placebo QD | Placebo, orally, once daily for up to 28 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 28 weeks. |
| BG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 28 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). | Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject. | Analysis was performed on all randomized subjects who took at least 1 dose of study drug and had a baseline serum urate ≥8.0 mg/dL. If subject prematurely discontinued from study before at least 3 serum urate levels were obtained, subject was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. | Posted | Number | Percentage of subjects | Last 3 visits (any last 3 visits up to week 28) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 28 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemias not elsewhere classified (NEC) | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea (Excluding Infective) | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research & Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
Not provided
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
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| Febuxostat | Drug | Febuxostat 120 mg, orally, once daily for up to 28 weeks. |
|
|
| Febuxostat | Drug | Febuxostat 240 mg, orally, once daily for up to 28 weeks. |
|
|
| Allopurinol | Drug | Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily. |
|
| Placebo | Drug | Placebo, orally, once daily for up to 28 weeks. |
|
The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject. |
| Final Visit (up to 28 weeks). |
| Percent Change From Baseline in Serum Urate Levels at Week 28. | Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized. | Baseline and Week 28 |
| Percent Change From Baseline in Serum Urate Levels at Final Visit | The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject. | Baseline and Final Visit (up to 28 weeks) |
| Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero. | Baseline and Week 28 |
| Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject. | Baseline and Final Visit (up to 28 weeks) |
| Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0. | Baseline and Week 28 |
| Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit | Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject. | Final Visit (up to 28 weeks) |
| Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. | Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once. | Weeks 8 through 28 |
| Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032. |
| 21353107 | Result | Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008. |
| 22052584 | Result | Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680. |
| Adverse Event |
|
| Personal Reason(s) |
|
| Other |
|
| Gout Flare |
|
| Protocol Violation |
|
| Therapeutic Failure |
|
| BG002 | Febuxostat 240 mg QD | Febuxostat 240 mg, orally, once daily for up to 28 weeks. |
| BG003 | Allopurinol QD | Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily. |
| BG004 | Placebo QD | Placebo, orally, once daily for up to 28 weeks. |
| BG005 | Total | Total of all reporting groups |
| subjects |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | subjects |
|
| Body Mass Index | Number | subjects |
|
| Presence of a Primary PalpableTophus | Number | subjects |
|
| Serum Creatinine | Number | subjects |
|
Febuxostat 80 mg, orally, once daily for up to 28 weeks. |
| OG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 28 weeks. |
| OG002 | Febuxostat 240 mg QD | Febuxostat 240 mg, orally, once daily for up to 28 weeks. |
| OG003 | Allopurinol QD | Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily. |
| OG004 | Placebo QD | Placebo, orally, once daily for up to 28 weeks. |
|
|
|
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28 | Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized. | Analysis was performed on intend to treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Number | Percentage of subjects | Week 28 |
|
|
|
|
| Secondary | Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit | The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected and may have differed by subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Number | Percentage of subjects | Final Visit (up to 28 weeks). |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Urate Levels at Week 28. | Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(Week 28 - baseline levels)/baseline]*100 and summarized. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Mean | Standard Deviation | Percent change | Baseline and Week 28 |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Urate Levels at Final Visit | The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as [(Final visit - baseline levels)/baseline]*100. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects. who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Mean | Standard Deviation | Percent change | Baseline and Final Visit (up to 28 weeks) |
|
|
|
|
| Secondary | Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | percent change from baseline | Baseline and Week 28 |
|
|
|
|
| Secondary | Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, who had a baseline serum urate ≥8.0 mg/dL, and who had a palpable primary tophus measured at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | percent change from baseline | Baseline and Final Visit (up to 28 weeks) |
|
|
|
|
| Secondary | Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit. | Change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were not palpable at the Week 28 visit, the total count was assumed to be 0. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | number of tophi | Baseline and Week 28 |
|
|
|
|
| Secondary | Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit | Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug,had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at the screening visit. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | number of tophi | Final Visit (up to 28 weeks) |
|
|
|
|
| Secondary | Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period. | Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once. | Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 28. | Posted | Number | percentage of subjects | Weeks 8 through 28 |
|
|
|
|
| 11 |
| 267 |
| 122 |
| 267 |
| EG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 28 weeks. | 9 | 269 | 123 | 269 |
| EG002 | Febuxostat 240 mg QD | Febuxostat 240 mg, orally, once daily for up to 28 weeks. | 5 | 134 | 72 | 134 |
| EG003 | Allopurinol QD | Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily. | 7 | 268 | 133 | 268 |
| EG004 | Placebo QD | Placebo, orally, once daily for up to 28 weeks. | 2 | 134 | 61 | 134 |
| Cardiomyopathies | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Coronary Artery Disorders NEC | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Ischaemic Coronary Artery Disorders | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Abdominal Hernias, Site Unspecified | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Duodenal and Small Intestinal Stenosis and Obstruction | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Gastrointestinal & Abdominal Pain, Excluding Oral,Throat | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Intestinal Ulcers and Perforation NEC | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Pain and Discomfort NEC | General disorders | MedDRA 7.0 | Systematic Assessment |
|
| Cholecystitis and Cholelithiasis | Hepatobiliary disorders | MedDRA 7.0 | Systematic Assessment |
|
| Abdominal and Gastrointestinal Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Device Failure and Malfunction | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Device Related Complications | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Non-Site Specific Procedural Complications | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Hypoglycaemic Conditions NEC | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
|
| Total Fluid Volume Decreased | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
|
| Muscle Weakness Conditions | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Osteoarthropathies | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Colonic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Endocrine Neoplasms Benign NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Endocrine Neoplasms Malignant and Unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Hodgkin's Disease NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Prostatic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Seizures and Seizure Disorders NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Transient Cerebrovascular Events | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Renal Failure and Impairment | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
|
| Bronchospasm and Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Lower Respiratory Tract Signs and Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Gastrointestinal & Abdominal Pains, Excluding Oral,Throat | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Influenza Viral Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Non-Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Liver Function Analyses | Investigations | MedDRA 7.0 | Systematic Assessment |
|
| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Muscle Related Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Musculoskeletal and Connective Tissues Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Headache NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Neurological Signs and Symptoms NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Vascular Hypertensive Disorders NEC | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Cochran-Mantel-Haenszel |
The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). |
| <0.001 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.011 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.091 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel |
The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). |
| <0.001 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.074 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | <0.001 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA |
| <0.001 |
P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA |
| <0.001 |
P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons. | 95 | No | Superiority or Other |
| 0.320 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.381 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.809 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.154 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.247 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.415 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.649 | Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.807 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.844 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.822 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.579 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.679 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.278 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.104 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.560 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.309 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.759 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.385 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.050 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.577 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.598 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.062 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.969 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.056 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.659 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.197 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.521 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.078 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.442 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.990 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.077 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.662 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.139 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.705 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.337 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.643 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel |
The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). |
| 0.756 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.428 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL) | 0.076 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.106 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.069 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.837 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.749 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.581 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| Cochran-Mantel-Haenszel | The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL). | 0.311 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |